EU GMP Annex 11 · 21 CFR Part 11 · ALCOA+
RCA, CAPA and effectiveness verification with ALCOA+ from the first record, 100% on your own server.
The status quo
Today deviations live in Excel, Word and email, with multiple versions and no clear owner. The RCA, CAPA and VoE chain breaks, effectiveness is never verified or only signed after the fact. When an AEMPS, EMA or FDA inspector shows up, QA spends days rebuilding the timeline on paper, and proving 21 CFR Part 11 and ALCOA+ becomes simply impossible.
What DeviTrack does
Critical, Major, Minor and Dual-Control templates with role pools, four-eyes approval, SLA timers and automatic escalation. Every transition is recorded.
5-Why and Ishikawa in connected tabs, CAPA stays open until effectiveness is verified, no shortcuts allowed.
PIN plus chained hash, actor, IP and timestamp on every critical transition, clearly marked in the UI and the exported DOCX. Append-only audit by design.
Suggests severity, finds similar past cases via RAG and drafts the inspector summary, all on Ollama or LM Studio inside your network.
One install, several subsidiaries with schema-isolated data, consolidated KPIs and a new tenant spun up in 30 seconds.
Why this is not another SaaS
DeviTrack is not a compliance SaaS that ships your batch data to the United States. It is a module that deploys on your own server with Docker Compose, no OpenAI, no Microsoft, no telemetry. The AI runs on open models inside the same building as the line, and the full CSV package (URS, FS, FMEA, IQ, OQ, PQ) ships signature-ready on day one.
No cloud, no telemetry, no US data transfer. Also runs in air-gap mode.
URS, FS, FMEA, IQ, OQ and PQ delivered signature-ready with the installation.
Shares authentication, RAG, chat and 40+ office tools with the rest of your platform.
For whom
Contract manufacturers (CMOs) of solid-dosage forms, biotech and pharma operations facing recurring AEMPS, EMA or FDA inspections. QA, QP and production share a single source of truth per site, with KPIs consolidated at group level.
30-minute demo on your own cases. Pilot deployment in four weeks.